Is Allantoin safe in cosmetics?
Allantoin has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. This ingredient has been reviewed by cir.
Allantoin
Also known as: 5-25-15-00338, BRN 0102364, Caswell No. 024, EINECS 202-592-8, EPA Pesticide Chemical Code 085701 (+15 more)
INCI: ALLANTOIN
Allantoin (CAS 97-59-6) is a cosmetic active ingredient functioning as Skin conditioner, keratolytic, anti-irritant, wound-healing agent; promotes. EU Regulation 1223/2009 status: permitted; 1 safety opinion reviewed (cir). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 97-59-6 →
Auto-generated CPSR Part A draft with source citations
Function
Skin conditioner, keratolytic, anti-irritant, wound-healing agent; promotes orderly cell turnover; stimulates fibroblast proliferation; typical use 0.5–2%
Safety Rating
EXCELLENT
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
OTC skin protectant active at 0.5-2.0% (21 CFR 347). Dual cosmetic/drug status. Wound healing claims = drug classification.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Allantoin.
Calculate MoS for your specific formulation with the MoS Calculator.
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
cir
Verdict: unknown
Dermal Penetration Profile
Skin absorption and penetration characteristics of Allantoin, relevant to systemic exposure and MoS calculations.
Absorption %
2-5%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
158.1 Da
Log P
-1.5
Systemic Absorption
minimal
Topical Bioavailability
1-3%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation
Source: CIR
EPA ToxValDB — Toxicity Values
2 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >=5000 mg/kg | Rat | dermal | - | ECHA IUCLID |
| LD50 | >5000 mg/kg | Rat | oral | - | ECHA IUCLID |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (1)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| GCC | halal_restricted | - | All cosmetics |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 0.1–0.5 | 2 | CIR/VCRP |
| Body Lotion | 0.1–0.5 | 2 | CIR/VCRP |
| Aftershave | 0.1–0.5 | 1 | CIR/VCRP |
Additional Ingredient Properties
10 property records from structured ingredient metadata.
acne
{"cas_number": "97-59-6", "anti_acne_mechanism": "anti_inflammatory/keratolytic", "comedogenicity_rating_0_to_5": "0", "acne_type_efficacy": "inflammatory/non_inflammatory", "sebum_reduction_pct_clinical": "0-5", "keratolytic_strength": "mild", "exfoliation_mechanism": "chemical", "peel_depth": "superficial", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentr…
anti_aging
{"anti_aging_claim": "barrier-repair, anti-inflammatory", "mechanism_of_action": "Building block for proteins, NMF component", "target_skin_layer": "epidermis", "collagen_stimulation": "Mild", "elastin_protection": "Mild", "wrinkle_reduction_pct": "5-10", "clinical_study_duration_weeks": "8", "sample_size": "25", "double_blind": "Yes", "placebo_controlled": "Yes", "published_journal": "Int J Cosme…
anti_pollution
{"cas_number": "97-59-6", "ingredient_class": "other", "primary_mechanism": "barrier_reinforcement", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation": "no", "NF_kB_inhibition…
baby_pediatric
{"cas_number": "97-59-6", "ingredient_class": "moisturizer_baby", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Keratolytic, soothing, promotes healing, well-tolerated", "transepidermal_absorption_risk_pediatric": "very_low", "dose_per_kg_body_weight_concern": "Topical benefits", "s…
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "0", "skin_type_suitability": "all,oily,dry,sensitive,combination,normal,acne-prone,rosacea", "acne_safe": "yes", "source": "Soothing"}
concentration
{"min_concentration_pct": "0.1", "max_concentration_pct": "0.5", "typical_concentration_pct": "0.3", "product_type": "Toner", "function_at_concentration": "Soothing", "source": "CIR Safety Assessment"}
cost_pricing
{"cost_tier": "budget", "estimated_cost_per_kg_usd_low": "15", "estimated_cost_per_kg_usd_high": "28", "natural_premium_markup_pct": "0", "organic_certified_premium_pct": "0", "supply_chain_volatility": "low", "primary_source_region": "China", "bulk_discount_threshold_kg": "200", "seasonal_price_variation": "low", "commodity_or_specialty": "specialty", "substitute_ingredients": "Panthenol, Bisabol…
deodorant
{"cas_number": "97-59-6", "ingredient_class": "skin_conditioning_deo", "mechanism_of_action": "other", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "0", "odor_reduction_pct": "0", "bacteriostatic": "no", "bactericidal": "no", "microbiome_impact": "neutral", "axillary_microbiome_effect": "varies by ingredient", "MIC_value_if_antimicrobial": "varies", "astringency_…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Fragrance
Humectant
Softener and conditioner
Regulatory List Membership (3)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
Expert Verdict
Expert safety assessment and concern-level summary for Allantoin.
Regulatory Flags
cir-safe-as-used-2010
us-otc-skin-protectant-21cfr347
mos-21846
dermal-absorption-5-20-pct
non-sensitizing-hript-n600
comedogenicity-0
cosmos-approved
readily-biodegradable
no-annex-listing
canada-symphytum-hotlist-risk
eu_children_restricted
ifra_fragrance
Known Synonyms
5-25-15-00338
BRN 0102364
Caswell No. 024
EINECS 202-592-8
EPA Pesticide Chemical Code 085701
Hydantoin, 5-ureido-
Uniderm A
5-Ureido-2,4-imidazolidindion
Cutemol emollient
UNII-344S277G0Z
Herpecin L
(2,5-diketoimidazolidin-4-yl)urea
(2,5-dioxoimidazolidin-4-yl)urea
(S)-allantoin
2,5-Dioxo-4-imidazolidinyl-urea
4-ureido-2,5-imidazolidinedione
5-Ureido-2,4-imidazolidindione
5-Ureido-Hydantoin
5-Ureidohydrantoin
AVC/Dienestrolcream
Chemical Function
Softener and conditioner
Humectant
Regulatory Lists
active_ingredient; Australia
inert_ingredient; non_food_use; Pesticides
pharmaceutical
active_ingredient; Europe; Pesticides
active_ingredient; animal_products; Europe; pharmaceutical; residue
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bath salts
children; Europe; Personal care - general moisturizing - hand/body lotion
Europe; Personal care
Europe; Personal care
Europe; Personal care
IFRA Transparency
Canada; pharmaceutical
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
ALLANTOIN
ChEMBL ID
CHEMBL593429
Max Phase
2
Adverse Event Associations
66
Frequently Asked Questions
Is Allantoin allowed in the EU?
Allantoin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Allantoin do in cosmetics?
Allantoin functions as: Skin conditioner, keratolytic, anti-irritant, wound-healing agent; promotes orderly cell turnover; stimulates fibroblast proliferation; typical use 0.5–2%. It is classified as a Active Ingredient in our database. CAS number: 97-59-6.
Is Allantoin used outside cosmetics?
Allantoin also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Allantoin compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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